Pharmaceutical manufacturers may be able to do away with dedicated cardiovascular outcomes trials (CVOTs) for new type 2 diabetes drugs, but it would come at the cost of having to conduct longer and more extensive Phase II/III studies that provide reassurance about CV safety, US FDA advisory committee members said Oct. 25.
Diabetes Drugs: Longer, Broader Phase II/III Trials Could Replace CV Outcomes Trials, US Panel Says
Premarketing trials that enroll more diverse patient populations and include targeted CV endpoint collection over longer periods of time could be sufficient to allow new type 2 diabetes drugs to reach market without need for a dedicated safety study, advisory committee members say, urging FDA to move away from current two-step approach to cardiovascular risk assessments.
